NCT04751760

Feasibility Study of a New Immunoglobulin E (IgE) Assay Method

Feasibility Study of a New Immunoglobulin E (IgE) Assay Method in Urine and Blood

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,376 (estimated)
• Sponsor: University Hospital, Toulouse · Academic / Other
• Sex: All
• Age: 6 Months – 99 Years
• Healthy volunteers: Not accepted

Summary

The main objective is to study the feasibility of a new specific IgE assay using a bioluminescence technique in a pediatric and adult allergic population. For this, we will collect blood, and urine during a blood test scheduled for the follow-up of the patient.

Detailed description

Allergy is a raising public health problem. Specific IgE assays are useful tools to investigate the physiopathology of allergies. This method is achieved mainly by the ImmunoCAP enzyme immunoassay technique. This is an expensive test that requires a significant amount of blood. This is a limitation particularly in children. The time to get the results is long and a second consultation has to be scheduled in order to communicate the results to the patients. The main objective of this study is to assess the feasibility of a new specific IgE assay, named LuLISA, using a bioluminescence technique in urine and blood samples from pediatric and adult allergic population. This technique was recently published for the quantification of IgE against two peanut allergens and needs to be extended for the detection of other major allergens. A secondary objective is the evaluation of the time needed to obtain results.

Conditions

• Allergy and Immunology

Interventions

Type	Name	Description
BIOLOGICAL	collection of blood and urine	blood and urine will be collected during a blood test scheduled for the follow-up of the patient

Timeline

• Start date: 2021-04-20
• Primary completion: 2026-04-20
• Completion: 2026-04-20
• First posted: 2021-02-12
• Last updated: 2026-03-19

Locations

2 sites across 1 country: France